Kornimate/medical-research-clean huggingface dataset:
the correlation between maternal infant bonding, pain and postpartum depression

Conditions: Maternal Care Patterns

Summary: the delivery process can be associated with significant maternal pain. which has many long and short term affects. the aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression.

delivery is a process that is correlated with maternal pain. the maternal pain can have signifcant long term and short term maternal and neontal impact. the most common method for pain reilef during delivery is epidural analgesia. few studies have examined the assocaition between use of epidural analgesia and postpartum depression, with some studies showing a postive correlation and other condricting so. maternal bonding is defined as her's emotional state, including maternal feelings towards the infant, it has proven to be the basis for the child's later attachment and sense of self. a stable and strong bond between mother and child is associated with positive parental behavior and of the child's cognitive and behavioral development, while a unstable maternal infant bond can may lead to long term matenal and infant complications. the aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression. in this study women the day after labor will be approched , following obtaining consent will be requested to fill out a the pbo vailadited maternal bonding questtionanire , the valadited epds (endinbough postpartum depression questionnaire) and a general questionnaire detailing their demographic , obstetric history and pain levels. at six weeks postpartum a member of the research team will call the study participant and ask the pbo and epds questionnaires to asses the correlation between delivery pain , maternal bonding and postpartum depression,

Eligibility criteria:
inclusion criteria: \*women whom have given birth at rabin medical center with the ability to follow study requirements. exclusion criteria: * women given birth to twins * women who's baby was hospitalized * women who were treated with magnesium * women who's babies were born with congenital malformations
a multinational, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and duration of effect of a single administration of various doses of cetrorelix sr in subjects with histologically confirmed endometriosis

Conditions: Endometriosis

Summary: identify effective doses of cetrorelix sr in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief


Eligibility criteria:
inclusion criteria: * premenopausal female, * history of regular menstrual periods, * any of the symptoms dysmenorrhea, * dyspareunia or pelvic pain assessed as moderate to severe, * endometriosis confirmed by histology within 36 months, * use of barrier contraception throughout the study exclusion criteria: * insufficient wash out period for other endometriosis treatments, * resection or destruction of endometriotic lesions less than 12 weeks prior to screening, * need for strong opioid analgesics, * need for immediate surgical treatment of endometriosis, * any condition that interferes with adherence to study procedures or study assessments

Keywords: endometriosis cetrorelix hormone symptoms relief safety tolerability pharmacodynamic pharmacokinetic
comparison of acute effects of traditional and drop set training on fatigue and proprioception in bodybuilding athletes

Conditions: Fatigue Intensity; Proprioception

Summary: to compare the acute effects of traditional and drop set training methods on fatigue levels and proprioceptive sensory mechanisms in bodybuilding athletes.

a total of 28 male bodybuilding athletes with an average age of 25.53 years from giresun and ordu provinces participated in the study voluntarily. the participants were randomly divided into two groups as traditional training group (gs) (n=14) and drop set training group (ds) (n=14). borg cr10 scale and myotonometric measurements (myoton pro muscle palpation device) were used to assess fatigue. myotonometric measurements were performed on the pectoralis major, triceps brachii and deltoideus muscles. proprioception characteristics were evaluated in four parameters: shoulder flexion, shoulder abduction, elbow flexion and wrist flexion using laser cursor-assisted angle repetition test. after the application, fatigue levels in pectoralis major, triceps brachii, borg cr10 parameters and proprioception errors in shoulder flexion, elbow flexion, wrist flexion parameters were significantly higher in the traditional set group compared to the drop set group.

Eligibility criteria:
inclusion criteria: * -being male. * being between the ages of 20-30. * to have been doing bodybuilding for at least the last five years. exclusion criteria: * -having undergone a serious surgical operation within the last year, * having used a performance enhancing product that affects the neuromuscular mechanism within the last year, * in addition, individuals who did not meet the inclusion criteria were excluded from the study.

Keywords: drop set traditional set fatigue proprioception
ascending multiple-dose study of brivanib alaninate in combination with chemotherapeutic agents in subjects with advanced cancers

Conditions: Advanced Cancer

Summary: to determine safety and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * histologic/cytologic diagnosis of advanced or metastatic solid tumors * life expectancy \>= 3 months * able to swallow tablets/capsules exclusion criteria: * pregnant or breastfeeding women * no more than 4 previous chemotherapy regimens in the advanced or metastatic setting (excluding prior adjuvant or hormonal / immuno / biologic antibody therapies

Keywords: metastatic, chemotherapy combination
reduction of peritoneal glucose uptake with use of sglt2 in humans undergoing peritoneal dialysis treatment

Conditions: End Stage Renal Disease; Peritoneal Dialysis Complication

Summary: end stage renal disease is annually diagnosed in about one thousand patients in denmark, and one of the treatment modalities in renal replacement therapy is peritoneal dialysis with about 25 % of patients assigned to this treatment (hommel2010). peritoneal dialysis is based on the principle of filtering waste products to peritoneal fluid and by exchange of peritoneal fluid eliminate waste products from the body. in peritoneal dialysis commonly used fluids contain glucose. exposure to high glucose levels in peritoneal fluid during peritoneal dialysis has several side effects. primarily, as glucose passes over and into the peritoneal membrane it causes local inflammation which leads to fibrosis over time (zhou2016). fibrosis limits the capacity of the exchange of water and waste products over the peritoneal membrane. the decrease of peritoneal exchange capacity is most commonly the reason for termination of peritoneal dialysis. sglt2-channels are identified in peritoneal mesothelial cells of rats (debray-carcia 2016), and most recently also in humans (shentu2021). an in vitro model of human peritoneal mesothelial cells incubated with the sglt2-inhibitor (empagliflozin) has shown significantly decrease in glucose uptake (zhou2019). exposure to intraperitoneal empagliflozin in rats, reduced the uptake of glucose over the peritoneal membrane significantly by 78 % and the ultrafiltration was increased (zhou2019). currently, to our knowledge, no clinical trials have been conducted in humans attending peritoneal dialysis with the aim of investigating either the effect or safety of sglt2i, as it is indeed the first of its kind, with the aim of including participants in peritoneal dialysis.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. age above 18 years of age 3. in stable peritoneal dialysis for more than 14 days. exclusion criteria: 1. in treatment with sglt2i currently or within the last 90 days. 2. treatment for peritoneal infection within the last 30 days. 3. any hospitalization within the last 30 days. 4. anaphylaxis to the imp. 5. impaired lever function with alat above normal range within the last 6 month. 6. sever efflux problems during peritoneal dialysis for the last 14 days, judged by the investigator. 7. non-menopausal defined as menstruation within the last 12 month without any other medical cause. only applicable for female participants. 8. substance abuse, judged by the investigator. 9. incapable to follow study protocol, judged by the investigator. 10. previously included in this clinical trial and exposed to the imp. 11. included in another clinical trial with exposure to any imp within the last 30 days.

Keywords: sglt2-inhibition dapagliflozin
an open-label crossover study to compare the relative bioavailability, efficacy and safety of epanova® and lovaza® in men and women with a history of pancreatitis

Conditions: Severe Hypertriglyceridemia

Summary: this is a randomized, open-label crossover study. the primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (epa), docosahexaenoic acid (dha), docosapentaenoic acid (dpa), and the ethyl esters of epa and dha in plasma from a single 2 g or 4 g dose of epanova® or 4 g lovaza®.


Eligibility criteria:
inclusion criteria: 1. male or female, ≥18 years of age; 2. history of serum tg concentration ≥500 mg/dl within the past 5 years; 3. have at least one episode of documented hospitalization for pancreatitis due to hypertriglyceridemia in his/her lifetime; 4. have no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of physical examination, ecg, medical history, and routine laboratory test results; 5. willing to maintain his/her current activity level and to follow either the ncep tlc diet with a caloric target for weight maintenance or a prescribed low-fat diet during the screening, treatment, and washout periods (visits 1 through 6b; weeks -4 through 12); 6. willing to eat the standardized breakfast, lunch, and dinner meals and snacks before and during visits 4b and 6b (weeks 4 and 12); 7. willing to abstain from alcohol consumption and avoid vigorous physical activity for 48 hours prior to visits 3 through 6b (weeks 0 through 12); and 8. subject understands the study procedures and is willing and able to sign the informed consent form to participate in the study and the health insurance portability and accountability act authorization for release of relevant protected health information to the investigators and study personnel. exclusion criteria: 1. an allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or any of the components of the standardized breakfast, lunch, or dinner meals or snacks (as described to them by study staff) 2. poorly controlled hypertension (resting blood pressure ≥160 mmhg systolic and/or ≥100 mmhg diastolic) prior to randomization (visit 3 \[week 0\]) 3. a history of cancer (other than basal cell carcinoma) in the last 2 years 4. a recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment), aortic aneurysm or resection, carotid endarterectomy, or revascularization procedure within the 6 months prior to visit 1
biodistribution and pharmacokinetics of pretomanid in tuberculosis patients using 18f-pretomanid pet

Conditions: Tuberculosis

Summary: this is an observational study that will examine the pretomanid pharmacokinetics (pk) in tuberculosis (tb) patients. dynamic 18f-pretomanid pet/ct will be performed after intravenous injection of 18f-pretomanid to determine multi-compartment, noninvasive determination of pretomanid pk in tb patients.


Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age at the time of consent and imaging 2. healthy subjects or subjects with confirmed tuberculosis or high suspicion of active tuberculosis by treating physician. 3. for tb patients: imaging evidence of suspected tuberculosis infection involving the lung, and possible additional other sites of involvement. 4. for tb patients: after tb diagnosis is confirmed, patients will be eligible to participate up to 6 weeks after starting tb treatment. 5. subject is willing to give written informed consent. subject is willing and able to comply with the protocol for the duration of the study including undergoing scheduled visits and study procedures. 6. screening clinical laboratory values must be within normal limits or judged not clinically significant by the investigator. 7. women of child-bearing potential (wocbp) must have a negative serum or urine pregnancy test within 24 hours prior to the radiotracer administration. 8. patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study-related procedures. exclusion criteria: 1. inadequate venous access 2. any medical condition that in the judgment of the investigator would make the patient inappropriate for entry into this study

Keywords: pet/ct pretomanid
left radial compared to femoral approach for coronary angiography in patients with previous cabg study

Conditions: Coronary Artery Disease; Vascular Access Complication

Summary: this randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of cabg surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.

patients from 4 different centers with a history of cabg are randomized 1:1 to left radial or femoral access. based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit δ = 5 minutes. the primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (net procedure time). secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.

Eligibility criteria:
inclusion criteria: 1. age over 18 years 2. written informed consent 3. clinical indication for coronary angiography in a patient with prior history of cabg 4. left radial artery has not been used as a graft during cabg exclusion criteria: 1. age over 90 years 2. patient's refusal to participate in the study 3. hemodynamic instability of the patient 4. failure to place a sheath at the randomization access site 5. arteriovenous fistula at the left upper limb 6. use of right internal mammary artery as a graft during cabg 7. creatinine clearance \<30 ml/min

Keywords: l-record radial femoral cabg coronary artery bypass graft
anti-nephropathic effects of chronic intermittent intravenous insulin therapy (ciiit)

Conditions: Diabetic Nephropathy; Diabetic Retinopathy

Summary: investigators with the goal of optimizing glycemic and blood pressure control saw type 1 diabetic patients weekly. a control group received 3-4 subcutaneous insulin injections per day; an intravenous insulin pulsed infusion group received, in addition, three one hour infusions in a pulsatile fashion over one eight hour period each week. patients were followed for 12 months with periodic testing of renal function by repeated blood and urinary analyses; diabetes control by blood testing and diabetes impact measurement score; cardiac and autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual changes with repeated fundus photography. the study hypothesis was that correction of respiratory quotient would correct the defect leading to microvascular complications of diabetes (type 1).


Eligibility criteria:
inclusion criteria: * type 1 diabetics with proteinuria willing to be seen weekly for the evaluation of renal function exclusion criteria: * associated active medical diseases that would not permit evaluation of stable renal disease over 18 months

Keywords: diabetic autonomic neuropathy
effects of exergames on vestibular function in healthy community dwellers.

Conditions: Vestibular Diseases

Summary: the aim is to assess the effects of virtual reality-based intervention on vestibular functions in healthy community dwellers.

elderly usually experience an age-related type of vestibular disorder, which involves vertigo, dizziness and poor postural stability. these symptoms seem to contribute to the "geriatric syndrome", which describes a complex symptomatology. it usually has multiple causes and must be considered interdisciplinary. this study will only consider healthy elderly with an expected age-related degeneration of the vestibular system. in terms of restoring vestibular functioning, compensation can be classified into adaptation, substitution and habituation. adaptation enhances the vestibulo-ocular reflex, which is equivalent to restoration. habituation on the other hand, accustoms the affected person to a conflicting situation, in order that the response of the vestibulo-ocular reflex is avoided. substitution is distinguished in literature between sensory and behavioral, in which the sensorial substitution transfers the importance given to proprioceptive and visual inputs and the behavioral substitution refers to avoidance strategies e.g. immobilization, increased blink reflex and prevention of head rotations. slower gait speed may also be a method used by elderly for compensation during a task when the base of support is unstable. considering recommendation future studies should incorporate examinations of functional gaze stability during typical daily tasks in more familiar settings as opposed to laboratory assessments. increased head movement may disturb balance and the risk of falling may be raised while walking stairs. as head stability is challenged during stair descent, elderly with age-related visual and vestibular impairment have problems with completing this quotidian task. a way to consider these observations in vestibular rehabilitation is the use of a virtual reality environment, which provides a motivating and pleasant method to train and that includes exercises requiring head turns. successful use of virtual reality in rehabilitation of vestibular patients has previously been implemented. however, these studies did not particularly to exercise head turns by completing an orientation task.

Eligibility criteria:
inclusion criteria: healthy community dwellers adult male and female participant's (≥65 years) signed informed consent after being informed exclusion criteria: benign paroxysmal positional vertigo acute pain walking disability (independent walking \<10 meters) uncontrolled cardiovascular disease (e.g.: uncontrolled blood pressure) weakness due to neurological problems
using teleneuropsychology to optimize cognition in healthy aging: the web-based breakfast game

Conditions: Healthy Aging

Summary: executive control processes involve initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. the proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control processes will improve cognitive performance in cognitively healthy older adults.

the proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control / multi-tasking abilities will improve cognitive performance in healthy older adults. cognitively normal adults aged 60-75 will be randomized into two experimental groups: 1) web-based game with training strategy; 2) web-based game without training strategy (active control). all participants (groups 1 and 2) will be instructed to play the complex, high-demand online game, breakfast game, for 14 one-hour sessions over 5 weeks.

Eligibility criteria:
inclusion criteria: * age 60-75 * willingness to adhere to training protocol * adequate english proficiency exclusion criteria: * low test scores (below 26 on the montreal cognitive assessment) * known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance. * taking medications known to influence cognitive performance. * sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation. * enrolled in a concurrent study that could affect the outcome of this study.

Keywords: cognition cognitive training non-pharmacological intervention video game cognitive enhancement computer-based teleneuropsychology computerized attention control executive control cognitive decline multi-tasking
long term evaluation of sarilumab in rheumatoid arthritis patients (saril-ra-extend)

Conditions: Rheumatoid Arthritis

Summary: main study: primary objective: assess the long term safety of sarilumab in participants with rheumatoid arthritis (ra). secondary objective: assess the long term efficacy of sarilumab in participants with ra. sub-study: this phase 3, open label sub-study was aimed to assess the usability of pfs-s when used by participants with moderate or severe ra, or their professional or non-professional healthcare providers in an unsupervised real-world situation. to mimic the real-world practice, the sub-study was incorporated into the lts11210 study without additional visits compared to the scheduled visits in the main study. the duration of this sub-study was 12 weeks.

the maximum duration of the study was up to 523 weeks: * up to 1-week of screening, if any. * at least 264 weeks of open label treatment phase and up to 516 weeks as maximum. * 6-week post-treatment follow-up as required per protocol.

Eligibility criteria:
inclusion criteria : main study: participants with ra who were previously randomized in the sarilumab ra clinical program: e.g., the efc11072 study, act11575 study, efc10832 study, sfy13370, and efc13752 study. sub-study: participants enrolled in the lts11210 study who were receiving either sarilumab 200mg q2w pfs or sarilumab 150mg q2w pfs and who were able and willing to participate in this sub-study. participants who had been enrolled in the main study for at least 24 weeks. participants must sign a sub-study written informed consent prior to any sub-study related procedure. exclusion criteria: main study: participants with any adverse event (ae) led to permanent study drug discontinuation from a prior study. participants with an abnormality(ies) or aes that per investigator judgment would adversely affect participation of the participant in the study. sub-study: there are no additional exclusion criteria to those defined in main study. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.